Sep 19, 2019 — recovery from, a catastrophic emergency. FCD 2 outlines the process for Executive Branch review and identification of essential functions.

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Public Health and Social Services Emergency Fund 2 T ABLE OF C ONTENTS O RGANIZATION C HARTS .. .. .. .. .. 9 Assistant Secretary for Preparedness and Response .. .. . 9 Cybersecurity .. .. .. .. . 10 Office of National Security .. .. .. . 11 I NTRODUCTION AND M ISSION .. .. .. 12 O VERVIEW OF B UDGET R EQUEST .. .. .. . 14 O VERVI EW OF P ERFORMANCE .. .. .. .. 16 A LL P URPOSE T ABLE .. .. .. .. .. 21 A PPROPRIATIONS L ANGUAGE .. .. .. 22 A MOUNTS A VAILABLE F OR O BLIGATION .. .. .. 24 S UMMARY OF C HANGES .. .. .. .. 25 B UDGET A UTHORI TY BY A CTIVITY .. .. .. . 26 A UTHORIZING L EGISLATION .. .. .. 27 A PPROPRIATIONS H ISTORY .. .. .. . 28 A PPROPRIAT IONS N OT A UTHORIZED BY L AW .. .. .. 29 A SSISTANT S ECRETARY FOR P REPAREDNESS AND R ESPONSE .. .. 30 Summary of Request .. .. .. . 30 Preparedness and Emergency Operations .. .. 34 National Disaster Medical System .. .. .. . 44 Civilian Volunteer Medical Reserve Corps .. .. 54 Hospital Preparedness Program .. .. .. . 59 Preparedness and Response Innovation .. .. .. . 82 Biomedical Advanced Research and Development Authority .. .. 85 Project BioShield .. .. .. .. .. 98 Strategic National Stockpile .. .. .. 103 Poli cy and Planning .. .. .. . 113 Operations .. .. .. .. 120 A SSISTANT S ECRETARY FOR A DMINISTRATION .. .. .. 123 Cybersecurity .. .. .. .. .. 123 N ONRECURRING E XPENSES F UND .. .. .. .. 132 I MMEDIATE O FFICE OF THE S ECRETARY .. .. .. 136 Office of National Security .. .. .. .. 136 P AND EMIC I NFLUENZA .. .. .. .. 139 A SSISTANT S ECRETARY FOR H EALTH .. .. .. .. 152

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Public Health and Social Services Emergency Fund 3 Homelessness .. .. .. .. .. 152 U.S Public Health Service (USPHS) Commissioned Corps Readiness Training .. . 154 B UDGET A UTHORITY BY O BJECT C LASS .. .. .. . 156 S ALARIES AND E XPENSES .. .. .. .. 157 D ETAIL OF F ULL – T IME E QUIVALENTS (FTE) .. .. .. . 158 D ETAIL OF P OSITIONS .. .. .. .. . 159 S UMMARY OF P ROPOSED C HANGES TO P ERFORMANCE M EASURES .. .. .. 16 0 G OOD A CCOUNTING O BLIGATION IN G OVERNMENT A CT (GAO – IG A CT ) R EPORT .. 167

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Public Health and Social Services Emergency Fund 4 We are pleased to present the Fiscal Year (FY) 2021 Congressional Justification for the Public Health and Social Services Emergency Fund (PHSSEF). The FY respond to, and recover from the consequences of a wide range of natural and man – made medical and public health threats and includes the FY 2021 budget justification for the Office of the Assistant Secretary for Preparedness and Response (ASPR), Cybersecurity, the Office of National Security (ONS), the Office of Global Affairs pandemic influenza program, and the U.S. Public Health Serv ice Commissioned Corps led by the Office of the Assistant Secretary for Health (OASH). Office of the Assistant Secretary for Preparedness and Response publi c health and medical response to disasters and public health emergencies, in accordance with the National Response Framework and Emergency Support Function #8. HHS also supports other federal entities who lead Emergency Support Function #6 with respect to the human and social services, including recovery. ASPR coordinates across HHS, the federal interagency, and supports state, local, territorial, and tribal health partners in preparing for and responding to emergencies and disasters. ASPR also enhances m edical surge capacity by organizing, training, equipping, and deploying federal public health and medical personnel and providing logistical support for federal responses to public health emergencies. At the state and local level ASPR supports readiness b y coordinating federal grants and cooperative agreements and carrying out drills and operational exercises. Through coordinating the Public Health Emergency Medical Countermeasures Enterprise, including the Biomedical Advanced Research and Development Aut hority (BARDA) and Strategic National Stockpile (SNS), ASPR oversees advanced research, development, procurement, and stockpiling of medical countermeasures (e.g. vaccines, medicines, diagnostics, and other necessary medical supplies). ASPR continues to r espond to catastrophic hurricanes and other natural disasters by activating National Disaster Medical System (NDMS) personnel to communities impacted by the storms. NDMS is supported by a workforce of up to 6,700 authorized intermittent federal employees o rganized into 71 teams. Throughout FY 2019, NDMS teams provided public health and medical support for the following: Hurricane Dorian in Florida and Puerto Rico, Presidential State of the Union Address, the National Police Officer Memorial, and the Nation al Independence Day Celebration, United Nations General Assembly, and Representative Elijah Cummings lying in state at the United States Capitol. NDMS teams contain clinical providers and specialized medical service professionals, including physicians, nur ses, fatality management professionals, paramedics, veterinarians, and other support staff, such as logisticians and information technology specialists. Years of investment have yielded this coordinated response; however more must be done to be able to pr epare and respond when disasters strike. To do this, ASPR supports health care coalitions, medical providers, and emergency managers in preparing for incidents that impact medical and public health capabilities. In addition, when an infectious disease ou tbreak occurs, the public expects immediate access to vaccines, diagnostics, and drugs as was seen during the 2009 H1N1 pandemic and the 2013 Ebola virus epidemic in Africa. However, having these products readily available requires long – range investment in time and funding for the research and development as well as the procurement of highly specialized products. To meet this public demand, protect health, and save lives in the next pandemic or disease epidemic, the federal government must continue to take action and maintain momentum to develop new medical countermeasures vaccines, drugs, diagnostics, and devices so they are available immediately when needed. Enhanced partnerships with small and large companies, sustained investments made possible und er Project BioShield (PBS), and funding provided for Pandemic Influenza preparedness over the last decade have successfully led to new capabilities and capacities, including medical countermeasures critical to national health security. These advances conti nue to boost

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Public Health and Social Services Emergency Fund 5 and nuclear agents, chemical agents, and emerging diseases. The medical countermeasure pipeline holds more promise today than ever to co mbat long – standing threats and newly emerging ones. federal agency does: the late stages of development necessary to reach licensure of medical products that prevent, diagnose, or treat illnesses or injuries from chemical, biological, radiological, and nuclear threats, as well as from emerging infectious diseases, pandemic influenza, and the growing public health threat of antimicrobial resistance. All of these threats pose a dire threat to American and globa l health. BARDA, in partnership with industry, has built a robust and formidable pipeline for advanced research and development of medical countermeasures. These efforts focus on combatting the medical consequences of 14 chemical, biological, radiological and nuclear threats identified by the Department of Homeland Security (DHS). These advanced development programs have supported 27 products that have transitioned to support under Project BioShield; 16 of these products have been procured for the SNS. B ARDA strategically supports advanced development and acquisition of medical countermeasures that are existing products and that can be repurposed to meet medical countermeasure needs or new multipurpose products with commercial indications that meet public needs. This approach increases the sustainability of these medical countermeasures, makes them less dependent on federal government support, and provides alternate mechanisms (e.g., vendor managed inventory systems) to stockpiling in the SNS. Pandemic In outbreak. These funds support the development of next – generation antivirals, ongoing activities to promote the development of rapid diagnostic assays for the diagnosis of pandemic influenza, and the accelerated development and production of influenza vaccine worldwide. On September 19, 2019, the White House reaffirmed that we must take deliberate, decisive, and comprehensive action to combat the threat of both seasonal and pandemic influenza with the issuance of an I nfluenza Vaccines in the United States to Promote National Security and Public Health to have a leadership role in the implementation of many key aspects of that plan. During 2019, BARDA continued to support expansion of domestic manufacturing capacity by issuing a six – year, $226 million contract to increase capacity to produce recombinant influenza vaccine in the United States. In FY 2021, BARDA will continue these efforts to expand manufacturing capacity along with subsequent lic ensure of pre – pandemic vaccine. In July 2016, BARDA established the Combating Antibiotic Resistant Bacteria Accelerator (CARB – X). CARB – X is a novel public – private – partnership aimed at promoting innovation in antibacterial drug, vaccine, and diagnostic development. CARB – X is a collabora tion between NIH’s National Institute of Allergy and Infectious Diseases (NIAID), BARDA, Boston University, the UK and German governments, Bill and Melinda Gates Foundation, and the Wellcome Trust, which aims to identify, build, and manage a portfolio of i nnovative antibacterial MCMs. As of January 2020, CARB – X has made awards to 53 different companies with six projects that have moved into human clinical trials. CARB – X is currently investing in novel vaccines targeting drug – resistant superbugs, non – trad itional approaches to treating bacterial infections, and next – generation antibiotics that overc ome known resistance mechanisms. C ARB – X has also invested in diagnostic platforms such as rapid point – of – care diagnostics and hospital laboratory – based diagnost ics. – made disease threats, the SNS, transferred to ASPR in FY 2019, engages in the procurement, maintenance, and deployment of medical countermeasures. The addition of th e SNS to ASPR is improving overall emergency response operations providing health and medical services to communities in need. Efficiencies are being identified across the medical countermeasure enterprise. In coordination with the Public Health Emergenc y Medical Countermeasures Enterprise, the SNS is implementing strategies to

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Public Health and Social Services Emergency Fund 6 meet the national priorities for federal stockpiling and to maintain and improve response capabilities as well as address inventory gaps. Through this, the enterprise will be more sustainable, productive, and effective at developing, stockpiling, and deploying the medical countermeasures needed to save lives and protect America from 21st Century health security threats. eption in 2006. To further improve national readiness and response capabilities, four key priority areas have been identified: G o al 1 Provide strong leadership. ASPR is a leader in both preparedness for and response to 21 st century health security threats. ASPR provides clear policy direction, and improved threat awareness, while continuing to secure adequate resources to manage the next health threat. ASPR will continue to coordinate with public health agencies as well as the Director of National Intelligence and the Department of Homeland Security to address current and future national security threats. G o al 2 Develop a Regional Disaster Health Response System. To address the potential catastrophic medical consequences of 21 st century threats, a tiered regional system based on existing local healthcare coalitions and trauma centers is needed. The Regional Disaster Health Response System (RDHRS) will leverage the modernization of the National Disaster Medical System, integrate all medical response capabilities, expand specialty care expertise in trauma and other threat and high risk areas, including pediatrics, and incentivize the healthcare system to integrate measures of preparedness into daily standards of care. G o al 3 Sust ain robust and reliable public health security capabilities. ASPR supports public health st century health threats. This is critical to rapidly and effectively dispense MCMs in an em ergency. ASPR has responsibility for the with CDC. G o al 4 Advance an innovative medical countermeasures enterprise. Biomedical Advanced Research and Development Authority (BARDA) has supported the advanced research and development of new MCMs. By using flexible, nimble authorities, multi – year advanced funding, strong public – private partnerships, an d cutting – edge expertise, BARDA has successfully advanced 53 innovative products to the Food and Drug Administration for approval, including ten in FY 2019 alone. ASPR will continue to develop and maintain a robust stockpile of MCMs capable of responding to 21 st century health threats. Enacted. The Budget provides: $1.1 billion for BARDA, including $562 million for Advanced Research and Development, and $535 mil lion for Project BioShield procurements of MCMs; $310 million for pandemic influenza preparedness activities by ASPR and the Office of Global Affairs; $705 million for the Strategic National Stockpile (SNS) to manage and deliver life – saving medical counter measures during a public health emergency; $258 million for the Hospital Preparedness Program to support cooperative agreements with state, local, and territorial health departments to improve surge capacity and enhance community health care coalitions;

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Public Health and Social Services Emergency Fund 8 As learned through public health threats such as Ebola and Zika, it is critical for the Department to respond quickly when such threats arise. To enable a swift response to emerging public health threats that have s ignificant potential to affect the health and security of U.S. citizens, the FY 2021 Budget re – proposes the establishment of a new transfer authority within the Office of the Secretary. HHS would have Department – wide transfer authority to help bridge the D exceed the planned scope of emergency preparedness and response programs and activities . Robert P. Kadlec Assistant Secretary for Preparedness and Response, Ph.D. Michael Schmoyer Assistant Deputy Secretary for National Security, Ph.D. Janet Vogel HHS Chief Information Security Officer Eric Hargan HHS Deputy Secretary

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Public Health and Social Services Emergency Fund 10 Cybersecurity Office of the Secretary Cybersecurity (OS) Julia White Cybersecurity Services Julie Chua Incident Management Vacant OS Vulnerability Management Nana Habib Chief Information Security Officer (CISO) Janet Vogel SES Deputy Chief Information Security Officer (DCISO) Chris Bollerer Security Technology and Information Management (STIM) Bob Barczynski Business Operations Eddie Blankenship TIC Travis Richardson Health Sector Cybersecurity Coordination Center (HC3) Greg Singleton Computer Security Incident Response ( CSIRC ) Jenn Saunders Advanced Cybersecurity Defense (ACD) Al Roeder Cybersecurity Operations James Antonucci Enterprise Security Services John Richardson Cybersecurity Governance Margarida Nighswander Cybersecurity Risk Management Vacant Cybersecurity Compliance Karla Gayle – C hambers Cybersecurity Architecture and Design Mark Deffenbaugh OS Compliance Management Davene Barton OS Data Guardian and Training Management Vacant

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